—#89008

Product

An Imaging device for medical procedures, to provide surgeons or operating room personnel the ability to capture still images and to record video during the surgical procedures in various file formats. Images can be transferred to external media.

FDA product code: LMB — Device, Digital Image Storage, Radiological
Device class: Class 1
Medical specialty: Radiology
Affected lot / code info: Product Name: SDC HD units and SDC HDi units Model Nuumbers: 240-050-888 and 240-050-888i Code: All SDC HD and SDC HDi units

Why it was recalled

Video device is not able to assign the correct time/date stamp.

Root cause (FDA determination)

Device Design

Action the firm took

Stryker Endoscopy has notified the 2865 domestic consignees affected by the device correction. The notification was mailed to affected consignees and their corresponding sales representatives. It included two mailings of the Urgent: Device Correction notice, SDC HD 3.0z correction software, and a SDC HD upgrade dongle. 100% of consignees have been contacted and notified of the device correction needed. The effectiveness of the correction has been tracked via acknowledgement cards mailed, faxed, or emailed. The local Stryker Sales Representative will install a software upgrade to fix this issue. Additional questions should be directed to the firm's Customer Service at (800)624-4422 or (408)754-2039.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: US government facilities and other US domestic consignees(nationwide), and to foreign countries

Timeline

Recall initiated: 2009-10-23
Posted by FDA: 2010-05-10
Terminated: 2011-02-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89008. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.